On November 2, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported the grant of a new patent (number ZL 201610221687) entitled "Use of recombinant LAG-3 or the derivatives thereof for eliciting a monocyte immune response" by the Chinese Patent Office (Press release, Immutep, NOV 2, 2021, View Source [SID1234594190]). The patent forms part of a broad and growing portfolio of patent families for the Company’s lead product candidiate eftilagimod alpha ("efti" or "IMP321") in key global markets including China.

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This new Chinese patent follows the grant of the corresponding European, Japanese and United States patents announced previously. The claims of the new patent relate to methods of use of (a) Immutep’s efti which is a LAG-3 fusion protein (LAG-3Ig) and (b) a chemotherapy agent in combination for the manufacture of a preparation for the treatment of cancer. The patent provides protection in mainland China and the expiry date is 3 October 2028.

The new patent is owned by Immutep S.A.S. and exclusively licensed to Immutep’s partner in China, EOC Pharma ("EOC").

Immutep CEO, Marc Voigt, noted: "We are making good progress building our global patent estate around our LAG-3 development pipeline, including lead candidate efti which has delivered promising clinical data in various settings. We will continue to make these important investments and are especially pleased to be working so closely with our Chinese partner, EOC Pharma, as they expand their clinical development of efti for the Chinese market."

EOC Pharma CEO, Xiaoming Zou, said: "We are investing in the development of efti for the local market in China and are very pleased with the steps being taken by our partner, Immutep, to build a broad portfolio of patent families around this unique candidate. These are important and ongoing steps in the complex process of bringing innovative medicines to the market for patients."

About efti in China

Efti is exclusively licensed by Immutep to EOC Pharma for the territory of Greater China (namely mainland China, Hong Kong S.A.R, Macao S.A.R. and Taiwan). Under its agreement with Immutep, EOC will make further milestone payments to the Company if efti achieves specific development milestones, as well as pay sales-based royalties. Immutep retains the rights to efti outside the territory of Greater China.

On November 2, 2021 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported third quarter 2021 financial results and provided a corporate update (Press release, Arca biopharma, NOV 2, 2021, View Source [SID1234594189]).

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Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, "The continuing pandemic and the emergence of multiple variants that have led to a resurgence of infections and hospitalizations, highlight the need for additional safe and effective therapeutic tools to treat patients that develop severe COVID-19. With rNAPc2’s combination of anticoagulant, anti-inflammatory and potential antiviral properties, we believe it has the potential to be effective in addressing COVID-19 impacts in hospitalized patients. Our international Phase 2b clinical trial is nearing completion and we look forward to sharing its results in the first quarter."

Pipeline Update

rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for COVID-19 and potentially other viral diseases.

On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19, enrolling patients at investigative sites in United States, Argentina and Brazil.
Clinical trial Data and Safety Monitoring Committee (DSMC) completed a pre-specified interim analysis and, based on the DSMC’s review of approximately 75% of the projected final efficacy and safety data, recommended completion of the clinical trial with no modifications to the clinical trial design.
Phase 2b topline data anticipated in first quarter of 2022.
GencaroTM (bucindolol hydrochloride) – a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

ARCA currently has an agreement with the U.S. FDA, known as a Special Protocol Assessment, or SPA, for the requirements of a Gencaro Phase 3 clinical trial, PRECISION-AF, that would support potential approval of Gencaro if successful. The Company is currently evaluating the potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial, and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.
Third Quarter 2021 Summary Financial Results

Cash and cash equivalents were $58.3 million as of September 30, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022.

Research and development (R&D) expenses were $3.4 million for the quarter ended September 30, 2021, compared to $1.1 million for the corresponding period in 2020. The $2.3 million increase in R&D expenses in the third quarter was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020. R&D expenses in 2021 are expected to be higher than 2020 as the Company continues the rNAPc2 Phase 2b clinical trial.

General and administrative (G&A) expenses were $1.3 million for the quarter ended September 30, 2021, compared to $0.9 million for the corresponding period in 2020. The $0.4 million increase in G&A expenses was primarily a result of higher personnel costs in 2021. G&A expenses in the last quarter of 2021 are expected to be consistent with the third quarter of 2021 as the Company maintains administrative activities to support its ongoing operations.

Total operating expenses for the quarter ended September 30, 2021 were $4.7 million compared to $2.0 million for the third quarter of 2020.

Net loss for the quarter ended September 30, 2021 was $4.7 million, or $0.33 per basic and diluted share, compared to $2.0 million, or $0.33 per basic and diluted share for the third quarter of 2020.

On November 2, 2021 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported approval of its Investigational Device Exemption ("IDE") application by the U.S. Food and Drug Administration ("FDA") to conduct a multi-center, randomized, double-arm study to evaluate the FDA breakthrough-device-designated Perimeter B-Series OCT imaging system that uses ImgAssist AI technology to identify regions of interest as compared with the current standard of care for patients undergoing breast conservation surgery (Press release, Perimeter Medical Imaging AI, NOV 2, 2021, View Source [SID1234594166]). It is anticipated that over 300 patients across 8 U.S. clinical sites will participate in the pivotal study to be led by Principal Investigator, Dr. Alastair Thompson at Baylor College of Medicine.

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Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "This IDE approval marks another important milestone in our ATLAS AI project, building upon the ‘Breakthrough Device Designation’ that we received in April, as we transition into clinical validation of the AI-enabled, next generation of our commercially available flagship OCT imaging technology. Trial start-up activities are already underway, with world-class sites and a number of the nation’s leading breast surgeons identified to participate in Perimeter’s pivotal study, which we anticipate initiating in mid-November at our first site at West Cancer Center’s Breast Center in Germantown, Tennessee under the direction of Dr. Richard E. Fine. Our hope is that the data generated from this trial supports our belief that Perimeter’s innovative OCT imaging technology will become a trusted tool for surgeons, resulting in better patient outcomes and lower healthcare costs."

Dr. Alastair Thompson, Principal Investigator and Professor, Section Chief of Breast Surgery and Olga Keith Wiess Chair of Surgery at Baylor College of Medicine and the Dan L Duncan Comprehensive Cancer Center said, "Currently, approximately one in four women who undergo breast conservation surgery require reoperation if their surgeon fails to get ‘clear’ margins. The goal of this pivotal study is to compare the use of Perimeter B-Series imaging technology with artificial intelligence against the standard of care and determine if it can improve surgeon’s ability to reduce re-operation rates for breast conservation surgery. Importantly, Perimeter’s novel imaging technology with AI fits into the routine surgical process with no additional imposition to the patient as it examines a tissue sample that is already being extracted. There is a strong medical need for tools to help surgeons identify if we have adequately removed the cancerous tissue real-time in the operating room and get it right the first time."

Dr. Richard E. Fine, Director of Education & Research, Margaret West Comprehensive Breast Center, West Cancer Center & Research Institute, commented, "I believe combining optical coherence tomography with artificial intelligence could represent the ‘next generation’ technology in specimen imaging. As breast cancer surgeons, we understand the physical, emotional, and financial stressors for patients that can come with needing a second surgery. The results from this study will not only help determine if this tool can assist physicians with improving patient outcomes but could also provide evidence of reducing the burden of additional costs within the overall healthcare system."

About Perimeter S-Series OCT

Cleared by the U.S. FDA, Perimeter S-Series Optical Coherence Tomography (OCT) is a novel medical imaging system that provides clinicians with cross-sectional, real-time margin visualization (1-2 mm below the surface) of an excised tissue specimen. Giving physicians the ability to visualize microscopic tissue structures "real time" in the operating room has the potential to result in better long-term outcomes for patients and lower costs to the healthcare system.

About Perimeter B-Series OCT with ImgAssist AI

Perimeter is advancing the development of its proprietary, next-gen "ImgAssist" artificial intelligence technology under its ATLAS AI project, which is made possible, in part, by a US$7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. FDA granted Breakthrough Device Designation for Perimeter B-Series OCT coupled with ImgAssist AI, and Perimeter is conducting a randomized, multi-site, pivotal study to evaluate it against the current standard of care and assess the impact on re-operation rates for patients undergoing breast conservation surgery.

On November 2, 2021 Moderna Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Metagenomi, Inc., a genetic medicines company with a versatile portfolio of next-generation gene editing tools, reported that the two companies have entered into a strategic research and development collaboration focused on advancing new gene editing systems for in vivo human therapeutic applications (Press release, Moderna Therapeutics, NOV 2, 2021, View Source [SID1234594164]). The collaboration will utilize Metagenomi’s novel gene editing tools and leverage Moderna’s mRNA platform, as well as lipid nanoparticle (LNP) delivery technologies, with the goal of developing curative therapies for patients with serious genetic diseases.

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"Metagenomi has demonstrated the power of its proprietary metagenomics approach that mines the Earth’s natural environment to discover next-generation gene editing tools and has developed discovery capabilities with the potential to address multiple diseases," said Eric Huang, PhD, General Manager & Chief Scientific Officer, Moderna Genomics (mGx). "Their discovery platform and expertise will expand Moderna Genomics’ ongoing efforts to develop innovative in vivo gene editing therapies to address a significant unmet medical need. This collaboration represents another milestone on our journey to create transformational genome-engineering based medicines."

"Gene editing has the potential to provide a cure for millions of patients living with genetic disease. Our partnership with Moderna is designed to accelerate the creation of genetic medicines using Metagenomi’s naturally derived, compact, modular and precise gene editing systems," said Brian C. Thomas, PhD, CEO and Co-Founder of Metagenomi. "This partnership will enhance our shared vision to forge transformative therapeutics for patients."

"Unlocking the therapeutic potential of gene editing requires a long-term commitment to develop the best technologies for both in vivo delivery and gene repair," said Jak Knowles, MD, CBO at Metagenomi. "We share Moderna’s goal to develop mRNA-based medicines, and we are thrilled to partner with them."

About the Collaboration

Under the terms of the collaboration, Metagenomi and Moderna will advance a series of in vivo gene editing therapeutics against undisclosed targets. Metagenomi will utilize its vast toolbox of gene editing systems in combination with Moderna’s mRNA and LNP technologies, to deliver next-generation therapies for genetic diseases. Metagenomi will receive an upfront cash payment and is eligible to receive certain target option exercise fees as well as development, regulatory and commercial milestone payments, plus tiered royalties on net sales of any products that are commercialized by Moderna. Moderna has also agreed to make an equity investment in Metagenomi in the form of a convertible note.

On November 2, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release third quarter 2021 financial results and provide a Company update after the market closes on Tuesday, November 9, 2021 (Press release, Cumberland Pharmaceuticals, NOV 2, 2021, View Source [SID1234594163]). A conference call and live internet webcast will be held on November 9 at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 9476299. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source